International Medical Affairs Director, Evidence Generation
Kyowa Kirin have an excellent new opportunity for an International Medical Affairs Director, Metabolic Bone Disease, Evidence Generation in our Marlow Office.
This role will be critical in creating and supervising delivery of evidence generation plans, which reflect prioritized needs from across the International markets and contribute to the future strategic development of the Metabolic Bone Disease Franchise. The role will also ensure creation and management of appropriate registries and publication plans and manage the process for approval and support of Investigator Initiated Studies.
- Liaise with Medical Affairs teams within major International Markets, to manage an annual process to identify data gaps and evidence generation opportunities which will enable and enhance market access, payer support, expert endorsement and successful commercialization of burosumab.
- Create propose and secure approval of Annual Evidence Generation Plan to include:
- A strategic overview of evidence generation needs in relation to burosumab Lifecycle Strategy, identifying gaps and providing context for new study proposals
- Prioritized or approved new study concepts, outline protocols, budget and timelines for proposed studies
- Study protocols, recruitment status, projected timelines and costs of ongoing studies
- Approved IIS protocols, including status, budgets and timelines (ongoing and proposed)
- The Early Access Programs and the XLH Patient Registry, including status and budget requirements
- Manage and develop the existing Patient Registry for subjects with XLH
- Manage and develop the existing Early Access Programs for burosumab in EMEA, and develop plans for potential extension of the program to adult patients
- Manage the process of assessing external study proposals (Investigator Initiated Studies) to secure input from relevant internal experts and support the approval decision-making process and financial management of the approved elements of the final budget, in support of
- Furthering understanding of the science of the underlying disease
- Furthering understanding of optimal disease management throughout the natural history of the disease
- Establishing the optimal role for KRN23 in XLH disease management
Key requirements include:
- Extensive iexperience industry experience, with previous experience in rare diseases and orphan drugs preferred
- Relevant scientific degree or appropriate certification, with medical qualification preferred
- Significant experience as ABPI medical signatory preferred
- Comprehensive understanding of industry medical governance norms, particularly with reference to compliance with all laws, regulations and industry codes of practice
- Exceptional track-record of success in clinical study design, planning and operational delivery
- Demonstrated ability to interact constructively and productively with affiliates and internal functions critical to the delivery of clinical evidence
- In-depth knowledge of the bone metabolism disease area
- In-depth understanding of the patient journey, treatment guidelines, issues and controversies relevant to optimal management of Metabolic Bone Disease and XLH
- Line management experience preferred
- Competitive salary
- Pension scheme
- Private medical insurance
Kyowa Kirin International is going through an exceptional time. With our imminent rare disease product launches and further new product development combined with excellent international growth rates, we are providing a great platform for today and our future.
The strength behind our success and future opportunities are our highly committed and skilled staff, supported by our parent company Kyowa Hakko Kirin - a Japanese Specialty Pharmaceutical company, whose substantial reinvestment into R&D is creating products at both early and late stage development. This prosperous time at Kyowa Kirin includes developing new teams, new departments and moving into exciting new areas.
Kyowa Kirin International is an equal opportunities employer.